A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00502710

Run by

Hoffmann-La Roche

People needed

289

Starts

2007-07-01

Expected to finish

2008-04-01

Last updated by the study team

2016-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age;
• type 2 diabetes diagnosed >= 1 month before screening;
• drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;
• BMI 25-45kg/m2.

You may not qualify if…

• type 1 diabetes;
• any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.

Where it is running

• Study site — Hot Springs, Arkansas, United States
• Study site — Concord, California, United States
• Study site — Los Angeles, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Avon, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Oxon Hill, Maryland, United States
• Study site — Troy, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Binghamton, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Beaver, Pennsylvania, United States
• Study site — Adelaide, Australia
• Study site — Canberra, Australia
• Study site — St Leonards, Australia
• Study site — São Paulo, Brazil
• Study site — São Paulo, Brazil
• Study site — Guatemala City, Guatemala
• Study site — Hong Kong, Hong Kong
• Study site — Aguascalientes, Mexico
• Study site — Chihuahua City, Mexico
• Study site — Guadalajara, Mexico
• Study site — Guadalajara, Mexico
• Study site — Mexico City, Mexico
• Study site — Pachuca, Mexico

Full record on ClinicalTrials.gov

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